Clearance Summary
KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti (IPS-Ti); Individual Patient Solutions - PEEK (IPS-PEEK); KLS Martin Individual Patient Solutions received FDA 510(k) clearance under submission number K260137, sponsored by KLS-Martin L.P.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2026-08-17.
- Submission: K260137
- Applicant / Sponsor: KLS-Martin L.P.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.4760
- Decision date: 2026-08-17
Classification & Regulation
This clearance is catalogued under FDA product code JEY and 21 CFR 872.4760, within the Dental review panel as a Class II device.